Medtronic Infuse is a medical device that is supposed to help re-grow bone in the spine, but it has become controversial because of safety concerns. Infuse has been linked to side effects such as cancer, male sterility and, excess bone. Most recently, in November 2013, a report posted on the National Center for Biotechnology Information(NCBI) website indicated that Medtronic’s Infuse bone graft product likely caused a life-threatening problem during revision surgery. Specifically, the report said that Infuse partially contributed to fibrosis and scarring that caused the iliac vein to adhere to the area of the patient’s spine that had been previously operated on, resulting in a life-threatening vascular injury during revision surgery.“Spine surgeons should be aware of this potential inflammatory fibrosis in addition to other reported complications related to rhBMP-2,” the authors noted.
Such complications seem to appear even more when the product is used off-label for unapproved procedures. To make matters worse, it appears that Medtronic has bribed docitors to hide the side effects associated with Infuse. Our firm has been handling defective drug and medical device issues for years, and is actively investigating Infuse cases. If you’ve had a procedure with Infuse, we’d like to hear from you. Call us today for free, no-obligation legal advice.
Side Effects Linked to Off-Label Use
Infuse contains recombinant human Bone Morphogenetic Protein-2 (rhBMP-2), a protein that stimulates bone growth. It is mostly meant for a type of spine surgery called lumbar fusion. The U.S. Food and Drug Administration (FDA) has only approved Infuse for anterior approach lumbar fusion, which is performed through the front of the body. Infuse is not approved for posterior lumbar fusion, which is performed through the back. Infuse has also been cleared for two types of dental surgery.
A drug or medical device is used “off-label” when it is used in ways not covered by its formal FDA approval. It is not illegal for doctors to use medicinal products off-label as they see fit, but it is illegal for companies to promote such uses. Infuse complications are the most prevalent in off-label procedures, such as when it is used in the cervical spine (neck). In fact, the FDA has warned that using Infuse in the cervical spine could lead to life-threatening complications, including swelling of the neck and throat.
Additional side effects and complications associated with Infuse include:
- Difficulty swallowing
- Difficulty breathing
- Difficulty speaking
- Ectopic or uncontrolled bone growth near the site of the surgery
- Nerve injuries that lead to severe, chronic pain
- Ongoing or chronic pain that radiates in the arms or legs
- Male sterility (retrograde ejaculation)
- Cauda equina syndrome (CES)
Did Medtronic Hide Infuse Complications?
Medtronic Infuse Bone Graft became even more controversial in June 2011 when a group of spine experts publicly denounced research funded by the company in a study published in the Spine Journal. The authors of that study alleged that Medtronic studies on Infuse failed to report side effects, such as cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. Contrary to what the Medtronic studies suggest, the Spine Journal researchers found that these complications occurred in 10 to 50 percent of patients who received Infuse in 13 Medtronic-funded trials conducted between 2000 and 2010. The review also questioned the financial relationship between the company and the researchers who did the studies; the median amount paid to the doctors was between $12 million and $16 million per study, although none of the royalty payments were related to Infuse.
A government investigation found evidence that the Medtronic-funded studies were biased. According to a United States Senate Finance Committee report, Medtronic employees helped write and edit 11 out of the 13 studies. This “ghostwriting” is not illegal, but it is considered a serious breach of integrity in the scientific community.
Judge Denies Medtronic’s Motion to Dismiss a Lawsuit Brought Over Infuse
In a recent consolidated class action lawsuit being tried in the U.S. District Court for the District of Minnesota and brought against Medtronic Inc. over its Infuse product, the judge denied Medtronic’s Motion to Dismiss. West Virginia Pipe Trades Health & Welfare Fund, Employees’ Retirement System of the State of Hawaii, and Union Asset Management Holding AG brought the lawsuit; the Court’s denial was made on September 29, 2014.
The allegations in this lawsuit include that Medtronic and some of its former and current officers, consultants, and executives were engaged in a scheme meant to mislead investors concerning Medtronic’s financial position, specifically concerning Infuse’s safety and efficacy. Allegations also include that initial studies showing the product’s safety and efficacy were shown to be inaccurate based on newer studies published in May and June 2011 in The Spine Journal. The journal article revealed that the incidence of Infuse adverse events was 10-50 times greater than previously published rates.
Other allegations include that Medtronic, in collaboration with physician consultants, were involved in a scheme to defraud investors by manipulating the initial studies. Because of this scheme to defraud, Medtronic’s stock traded at falsely inflated prices during the Class Period, dropping nearly 25 percent from its highest level once the truth was revealed, according to lawsuit allegations.
The lawsuit cited violations of the Securities and Exchange Act; a scheme and course of conduct intended to mislead; and violations of the Exchange Act.
If you or a loved one suffered any of the above injuries after undergoing a procedure with Medtronic Infuse, you may have valuable legal rights. To learn more about how our personal injury attorneys can help you, please fill out our online form or call us at 1-800-YOURLAWYER (1-800-968-7529).